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Notably absent from last month’s Department of Health and Human Services Semiannual Regulatory Agenda was any indication of where the Centers for Medicare and Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") stand with respect to their notice with request for comments, issued last fall, on the proposed parallel review process for medical products
On December 19, 2011, the Centers for Medicare & Medicaid Services published a proposed rule related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act”
As most medical device manufacturers are aware, states are increasingly imposing marketing restrictions on device manufacturers through laws that previously focused more specifically on pharmaceutical manufacturers
